Active holder for annuloplasty ring delivery

ABSTRACT

An active annuloplasty ring holder having a template that can be folded or pivoted to the side allowing the template to align longitudinally with the handle and enter the patient&#39;s chest through a small incision. The holder may include a mechanism to remotely detach sutures fastening the ring to the holder, thereby detaching the ring while avoiding the risk associated with introducing a scalpel into the operating field. A detachment mechanism may include a movable pin actuated by a pull wire that releases a plurality of holding sutures, or a hot wire, knives, or pull wire that severs the sutures. The holder may have a built-in light source for better visualization of the ring inside the heart. The holder may also have an optical means of visualizing the inside of the heart from the proximal end of the handle.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/809,049, filed Jul. 24, 2015, U.S. Pat. No. 10,085,837,which is a continuation of U.S. patent application Ser. No. 13/762,236,filed Feb. 7, 2013, U.S. Pat. No. 9,101,472, which is a divisional ofU.S. patent application Ser. No. 12/206,604, filed Sep. 8, 2008, U.S.Pat. No. 8,377,117, which claims priority to U.S. Provisional PatentApplication No. 60/970,872, filed Sep. 7, 2007, the disclosures of whichare incorporated by reference herein in their entireties.

FIELD OF THE INVENTION

The present invention relates to a method for delivering a cardiacimplant to a heart valve annulus and, more particularly, to a method fordelivering and facilitating implant of an annuloplasty ring using anactive holder.

BACKGROUND OF THE INVENTION

Heart valve disease is a widespread condition in which one or more ofthe valves of the heart fails to function properly. Diseased heartvalves may be categorized as either stenotic, wherein the valve does notopen sufficiently to allow adequate forward flow of blood through thevalve, or incompetent, wherein the valve does not close completely,causing excessive backward flow of blood through the valve when thevalve is closed. A heart valve may also be both stenotic andincompetent. Valve disease can be severely debilitating and even fatalif left untreated, particularly if the diseased valve is the mitralvalve (between the left atrium and left ventricle) or the aortic valve(between the left ventricle and the aorta). According to recentestimates, more than 80,000 patients are diagnosed with aortic or mitralvalve disease in U.S. hospitals each year.

Various surgical techniques may be used to repair a diseased or damagedvalve. One repair technique which has been shown to be effective intreating incompetence, particularly of the mitral and tricuspid valves,is annuloplasty, in which the effective size of the valve annulus iscontracted by attaching a prosthetic annuloplasty ring to an interiorwall of the heart around the valve annulus. The annuloplasty ringcomprises an inner substrate of a metal such as stainless or titanium,or a flexible material such as silicone rubber or Dacron cordage,covered with a biocompatible fabric or cloth to allow the ring to besutured to the heart tissue. The annuloplasty ring may be stiff orflexible, may be split or continuous, and may have a variety of shapes,including circular, D-shaped, C-shaped, or kidney-shaped. Examples areseen in U.S. Pat. Nos. 4,917,698, 5,061,277, 5,290,300, 5,350,420,5,104,407, 5,064,431, 5,201,880, and 5,041,130, which are incorporatedherein by reference.

Using current techniques, most valve repair and replacement proceduresrequire a gross thoracotomy, usually in the form of a median sternotomy,to gain access into the patient's thoracic cavity. A saw or othercutting instrument is used to cut the sternum longitudinally, allowingtwo opposing halves of the anterior or ventral portion of the rib cageto be spread apart. A large opening into the thoracic cavity is thuscreated, through which the surgical team may directly visualize andoperate upon the heart and other thoracic contents. Alternatively, athoracotomy may be performed on a lateral side of the chest, wherein alarge incision is made generally parallel to the ribs, and the ribs arespread apart and/or removed in the region of the incision to create alarge enough opening to facilitate the surgery.

Using such open-chest techniques, the large opening provided by a mediansternotomy or right thoracotomy enables the surgeon to see the mitralvalve directly through the left atriotomy, and to position his or herhands within the thoracic cavity in close proximity to the exterior ofthe heart for cannulation of the aorta and/or coronary arteries toinduce cardioplegia, manipulation of surgical instruments, removal ofexcised tissue, and introduction of an annuloplasty ring or areplacement valve through the atriotomy for attachment within the heart.However, these invasive, open-chest procedures produce a high degree oftrauma, a significant risk of complications, an extended hospital stay,and a painful recovery period for the patient. Moreover, while heartvalve surgery produces beneficial results for many patients, numerousothers who might benefit from such surgery are unable or unwilling toundergo the trauma and risks associated with open-chest procedures.

Annuloplasty ring prostheses are generally mounted on a holder assemblyto facilitate their manipulation during the course of a surgicalintervention and their implantation. Current holder assemblies arecharacterized by a number of drawbacks. A great majority of holders areconfigured with a rigid handle and a fixed orientation of the holderbody or prosthesis carrier relative to the handle. Such a mechanicallimitation does not allow the surgeon to orient the holder body relativeto the handle in order to optimize the delivery of the prosthesis to theimplant site. Some holder assemblies have been configured with malleablehandles in an attempt to alleviate this drawback. However, suchmalleable handles are generally difficult to reshape in different bentconfigurations once they have been initially bent. Some holderassemblies have introduced shape memory alloys, such as Nitinol, for thematerial of the handle. Handles made from Nitinol that would be bentduring the surgical procedure would resume their straight unbent shapeafter being exposed to sterilization temperatures. However, Nitinolhandles are expensive and may be too easy to bend out of desired shapewhen the cardiac prosthesis mounted on end of such handles is exposed totissue or suture loads during the surgical intervention.

In view of actual and perceived drawbacks associated with currentannuloplasty techniques, there is a need for a less invasive approachand improved handle.

SUMMARY OF THE INVENTION

In one aspect, the present application discloses a holder for deliveringan annuloplasty ring, comprising a template having a peripheral edgesized to receive an annuloplasty ring. A plurality of sutures attach theannuloplasty ring to the template, and the holder includes a handlehaving a pivot on which the template pivots to a variety of angles withrespect to the handle. A ring detachment mechanism detaches the suturesattaching the annuloplasty ring to the template, and is remotelyactuated from the handle. Also, a pivoting mechanism in the handlepivots the template.

The pivoting mechanism may include a gear train or a pulley system. In apreferred embodiment, the pivoting mechanism includes a push/pull rodlinearly movable within the handle and connected to an eccentricprojection of a pivot member on which the template mounts. The holdermay further include a locking mechanism in the handle that permits auser to fix the angle of the template with respect to the handle.Desirably, the pivoting mechanism enables approximately 180° of rotationof the template.

The ring detachment mechanism may include hot wires, blades or a pullwire that sever the sutures attaching the annuloplasty ring to thetemplate. Preferably, the ring detachment mechanism includes a pullwire, and the plurality of sutures attaching the annuloplasty ring tothe template loop around a release pin movable in a bore in thetemplate, the pull wire being connected to and able to displace therelease pin to detach the annuloplasty ring from the template. In oneembodiment, the release pin is movable in a bore in the template betweenan extended position around which the plurality of sutures loop toattach the annuloplasty ring to the template, and a retracted positionthat frees the suture loops to detach the annuloplasty ring from thetemplate. Preferably, the holder further include a plurality of suturesattaching the handle to the template. A handle detachment mechanism fordetaching the sutures attaches the handle to the template, and isremotely actuated from the handle.

Another aspect of the present application is a holder for delivering anannuloplasty ring comprising a proximal handle and a template mounted onthe distal end of the handle having a peripheral edge sized to receivean annuloplasty ring. A source of illumination mount on the handle andis directed toward the template. The source of illumination is desirablymounted at the end of a malleable wire extending along the handle,wherein a portion of the handle is also malleable. An optic lens mayalso be mounted on the handle directed toward the template, and a viewermounted at a proximal end of the handle permits a user to visualize thetemplate through the lens.

A further aspect herein is a holder for delivering an annuloplasty ringthat comprises a proximal handle and a template mounted on the distalend of the handle having a peripheral edge sized to receive anannuloplasty ring. An optic lens mounts on the handle and is directedtoward the template, and a viewer mounted at a proximal end of thehandle permits a user to visualize the template through the lens.

Another holder for delivering an annuloplasty ring disclosed hereinincludes a template having a peripheral edge sized to receive anannuloplasty ring, and a plurality of sutures attaching the annuloplastyring to the template. A handle attaches to the template, and a ringdetachment mechanism detaches the sutures attaching the annuloplastyring to the template, and is remotely actuated from the handle. The ringdetachment mechanism may includes hot wires, blades or a pull wire thatsever the sutures attaching the annuloplasty ring to the template.

Preferably, the plurality of sutures attaching the annuloplasty ring tothe template loop around a release pin movable in a bore in thetemplate, and the pull wire connects to and displaces the release pin todetach the annuloplasty ring from the template. In one embodiment, therelease pin is movable in a bore in the template between an extendedposition around which the plurality of sutures loop to attach theannuloplasty ring to the template, and a retracted position that freesthe suture loops to detach the annuloplasty ring from the template. Theholder further may include a pull wire in the handle connected on adistal end to the release pin and on a proximal end to a ring releasebutton in the handle. A user may displace the release pin from theextended position to the retracted position by pulling the ring releasebutton. The pull wire may connect on its proximal end to a pulleymounted to translate with the ring release button, wherein the pulley isfree to rotate unless the user pulls the ring release button.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of the present invention will become appreciatedas the same become better understood with reference to thespecification, claims, and appended drawings wherein:

FIG. 1 is a perspective view of an exemplary active annuloplasty ringholder;

FIG. 1A is a close-up perspective view of a distal end of the holder ofFIG. 1 showing a pivoting annuloplasty ring template;

FIGS. 2A and 2B are front and side elevational views of the holder ofFIG. 1;

FIGS. 3A-3C are close-up side elevational views of the distal end of theholder of FIG. 1 showing the template in several possible angularorientations;

FIG. 4 is a perspective exploded view of the exemplary activeannuloplasty ring holder of FIG. 1;

FIG. 5 is a perspective assembled view of the holder of FIG. 1;

FIG. 6 is a perspective view of another exemplary active annuloplastyring holder;

FIGS. 6A and 6B are close-up perspective views of a distal end of theholder of FIG. 6 showing a pivoting annuloplasty ring template;

FIGS. 7A and 7B are front and side elevational views of the holder ofFIG. 6;

FIG. 8 is a perspective exploded view of the exemplary activeannuloplasty ring holder of FIG. 6;

FIG. 9 is a perspective assembled view of the holder of FIG. 6;

FIG. 10 is a perspective view of the distal end of a further exemplaryannuloplasty ring holder illustrating a mechanism for remotely detachingthe annuloplasty ring from the holder that uses hot wires;

FIG. 10A is a close-up schematic view of the detaching operation of thehot wires of the holder of FIG. 10;

FIG. 11 is a perspective view of the distal end of a further exemplaryannuloplasty ring holder illustrating a mechanism for remotely detachingthe annuloplasty ring from the holder that uses severing blades;

FIG. 11A is a close-up schematic view of the detaching operation of thesevering blades of the holder of FIG. 11;

FIG. 12 is a perspective view of the distal end of a further exemplaryannuloplasty ring holder illustrating a mechanism for remotely detachingthe annuloplasty ring from the holder that uses pull wires;

FIG. 12A is a close-up schematic view of the detaching operation of thepull wires of the holder of FIG. 12;

FIG. 13 is a side view of an annuloplasty ring holder having a source ofillumination;

FIG. 14 is a side view of an annuloplasty ring holder having both asource of illumination and means for visualization;

FIGS. 15A and 15B are perspective and front elevational views of analternative active annuloplasty ring holder;

FIG. 16A is a close-up perspective view of an actuating button on ahandle of the ring holder of FIG. 15A;

FIG. 16B is a sectional perspective view of the actuating button with aportion of the handle removed to illustrate a locking mechanism therein;

FIG. 17 is a sectional perspective view of a distal segment of the ringholder of FIG. 15A with a portion of the handle removed to illustrate aninner template pivoting mechanism;

FIGS. 18A-18E are longitudinal sectional views of the distal end of thering holder of FIG. 15A showing a number of positions in which anannuloplasty ring template may be pivoted;

FIGS. 19A-19D are perspective views of the annuloplasty ring template ofthe holder of FIG. 15A showing a mechanism for securing and detaching anannuloplasty ring around the template;

FIGS. 20A and 20B are longitudinal sectional views through the distalend of the holder and annuloplasty template of FIG. 15A illustrating theoperation of two pull wires for releasing the annuloplasty ring and thehandle, respectively, from the template;

FIGS. 21A and 21B are perspective views of the proximal end of thehandle with a portion removed to show operation of both ring and handlerelease actuators therein;

FIG. 22 is a distal perspective view of the annuloplasty ring templateassembled with a release pin cover thereon; and

FIG. 23 is a distal perspective view of an alternative annuloplasty ringtemplate similar to that of FIG. 15A but with spokes and windows forgreater visibility.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Annuloplasty rings for valve repair are provided to surgeons with theholder to help facilitate the implantation of the ring in a human heart.The holder typically comprises a handle on the distal end of which isprovided a template for mounting the annuloplasty ring. The handle maybe designed to permit the surgeon to angle the template into a desiredorientation. The template is rigid and has an outer peripheral edge inthe shape of the annuloplasty ring. The rigid template helps maintainthe desired form of the ring during this suturing process. The preferredmethod of mounting an annuloplasty ring to a template is using suturesthreaded through the suture-permeable ring and attached to the template.In this context, “suture” refers to any biocompatible flexible filamentthat has sufficient strength to hold the ring in place around thetemplate.

The surgeon delivers the ring to the implantation site on the templateand sutures the ring into place prior to removing the template. Afterimplantation, by severing each attaching suture, the template is pulledfree from the ring and removed from the implantation site. Although,such holders are useful for open-chest procedures but are generallyill-suited for delivering rings through small incisions such as thoseused in less-invasive surgical or percutaneous procedures.

An active annuloplasty ring holder well-suited for delivering ringsthrough small incisions and also having features as yet unavailable, andhaving the following advantages is disclosed:

1. The holder and ring section can be folded or pivoted to the sideallowing them to align longitudinally with the handle and enter thepatient's chest through a small incision.

2. The handle includes a mechanism that can be operated remotely, e.g.,from outside the patient's body, to sever sutures fastening the ring tothe holder, thereby detaching the ring from the holder, without the needto introduce a scalpel into the heart, thus avoiding the risk associatedwith such introduction.3. The handle has a built-in light source for better visualization ofthe ring inside the heart.4. The handle has an optical means of visualizing the inside of theheart from the proximal end of the handle.

Each of the above features can be implemented individually, or incombination with the other features.

With reference to FIGS. 1 and 1A, an exemplary active annuloplasty ringholder 20 comprises a proximal handle 22 having a hub 24 on a distal endon which a template 26 pivotally mounts. Although not shown, thetemplate 26 is adapted to receive and secure thereon an annuloplastyring around its periphery. In the illustrated embodiment, the template26 is designed for delivering a mitral annuloplasty ring, and as suchhas a modified oval shape with the majority being convex and one sidesomewhat linear. The convex side receives the posterior aspect of themitral annuloplasty ring, while the more linear side receives theanterior aspect of a continuous ring, or in the case of a discontinuous,C-shaped ring, no part of the ring extends along the linear side.

As mentioned, the template 26 pivots about the hub 24 via a pivotingmechanism 28, shown in more detail below with respect to FIG. 4. Thehandle 22 includes a proximal grip 30 and a malleable section 32 thatextends between the grip and the hub 24. A rotation wheel 34 preferablyactuated with the user's thumb projects outward about midway along thegrip 30. Rotation of the wheel 34 causes pivoting movement of thetemplate 26, as will be described.

FIGS. 2A and 2B are front and side elevational views of the holder 20 ofFIG. 1. In an exemplary embodiment, the overall length A of the holder20 is between 200-250 mm, and preferably 230 mm. The malleable section32 has a length B of between 80-120 mm, and preferably about 100 mm.

FIGS. 3A-3C are close-up side elevational views of the distal end of theholder 20 of FIG. 1 showing the template 26 in several possible angularorientations. FIG. 3A shows the template 26 oriented in a typicalimplant position with the plane of the template perpendicular to thelongitudinal axis of the hub 24. If the hub 24 is aligned with the restof the handle 22, the template 26 is also perpendicular to the handle.FIG. 3A illustrates the template 26 at 0°, FIG. 3B shows the template atan angle of −45°, while FIG. 3C shows the template at an angle of 90°.Desirably, the pivoting mechanism 28 enables the template 26 to bepivoted up to 180° through its range of motion.

FIG. 4 is a perspective exploded view, and FIG. 5 a perspectiveassembled view, of the exemplary active annuloplasty ring holder 20 ofFIG. 1 illustrating the various moving parts. In particular, thepivoting mechanism 28 comprises the aforementioned rotation wheel 34journaled for rotation within the hollow grip 30. The rotation wheel 34has a pulley 35 around which runs an elongated flexible transmission,such as a cord or belt 36. The belt 36 passes alongside a malleablestylet 38 within the handle 22 and into a hollow space within the hub24. The belt 36 then passes around a second pulley 40 which is journaledfor rotation about a pivot 42 in the hub 24. A key 44 rigidly affixed tothe pulley 40 fits closely within a recess 46 on the underside of thetemplate 26. Upon rotation of the wheel 34, the belt conveys rotationalmovement to the pulley 40, which in turn pivots the template 26 via theconnection of the key 44 and recess 46. In this way, the user can easilypivot the template 26 using a thumb or finger on the rotational wheel34. A spring 48 with relatively tight coils surrounds the belt 36 andstylet 38 to provide protection for the belt without sacrificingmalleability.

FIG. 6 is a perspective view of another embodiment of an activeannuloplasty ring holder 60 of the that comprises a proximal handle 62having a hub 64 on a distal end on which a template 66 pivotally mounts.Although not shown, the template 66 is adapted to receive and securethereon an annuloplasty ring around its periphery. In the illustratedembodiment, the template 66 is designed for delivering a mitralannuloplasty ring, and as such has a modified oval shape with themajority being convex and one side somewhat linear.

As mentioned, the template 66 pivots about the hub 64 via a pivotingmechanism 68, shown in more detail below with respect to FIGS. 6A, 6Band 8. The handle 62 includes a proximal grip 70 and a malleable section72 that extends between the grip and the hub 64. A rotation knob 74extends from the proximal end of the grip 70. Rotation of the knob 34about the handle axis causes pivoting movement of the template 66, aswill be described.

FIG. 8 is a perspective exploded view, and FIG. 9 a perspectiveassembled view, of the active annuloplasty ring holder 60 of FIG. 6illustrating the various moving parts. In particular, the pivotingmechanism 68 comprises the aforementioned rotation knob 74 journaled forrotation on the proximal end of the hollow grip 70. The rotation knob 74rigidly connects to an elongated shaft 76 that passes alongside amalleable stylet 78 within the handle 62 and terminates at a distaldrive bevel gear 80. The bevel gear 80 engages a driven bevel gear 82which is journaled for rotation about a pivot 84 in the hub 64. A key 86rigidly affixed to the driven bevel gear 82 fits closely within a recess88 on the underside of the template 66. Upon rotation of the knob 74,the shaft 76 conveys rotational movement to the drive bevel gear 80,which in turn rotates the driven bevel gear 82, and in turn the template66 via the connection of the key 86 and recess 80. In this way, the usercan easily pivot the template 66 using two fingers on the rotationalknob 74. A spring 90 with relatively tight coils surrounds the shaft 76and stylet 78 to provide protection without sacrificing malleability. Inone embodiment, the shaft 76 comprises a coil of material so as toenable bending while still being capable of applying torque to the geartrain.

FIG. 10 is a perspective view of the distal end of a further embodimentof an annuloplasty ring holder 100 illustrating a mechanism for remotelydetaching the annuloplasty ring AR from the holder. As in the earlierembodiments, the holder 100 includes a proximal handle 102 having a hub104 on the distal end, and the template 106 connected to the hub 104.The remote detachment mechanism may be utilized by itself in aconventional holder/template configuration, or may be coupled with anyof the template pivoting mechanisms as described above.

The annuloplasty ring AR attaches around the arcuate periphery of thetemplate 106 via a plurality of attachment sutures 108. Preferably,there are three loops of attachment sutures 108 relatively evenly spacedaround the template 126. In a preferred embodiment, each of theattachment sutures 108 loops through a portion of the body of thesuture-permeable ring AR and up over a groove provided in a guide 112.The guides 112 desirably comprise small steps or blocks projectingupward from a top surface 114 of the template 106. A hot wire 116extends radially outward from within the hub 104 and loops around eachone of the attachment suture loops 108. The wire 116 may be insulatedexcept for a section which loops around the suture 108.

At an appropriate time, such as after the annuloplasty ring AR has beentranslated into its implant position but prior to tying implant knots,the wire 116 may be energized by a circuit passing through the handle102 so that it heats up and cuts through the attachment suture 108. Abattery and actuation button are desirably incorporated into the handle102, and wires with some slack to enable bending or pivoting connect tothe hot wires 116. FIG. 10A is a close-up schematic view of thedetaching operation of the hot wires 116. In this way, each of theattachment sutures 108 can be simultaneously remotely severed at theguide 112. One or both ends of the severed attachment sutures 108 aresecured to the template 106 so that the user can remove the template andall of the attachment sutures from the ring AR at the same time. In oneembodiment, the hot wires 116 are printed onto a circuit board thatforms a part of the template 106.

FIGS. 11 and 11A are perspective views of the distal end of a furtherexemplary annuloplasty ring holder 120 illustrating an alternativemechanism for remotely detaching the annuloplasty ring AR from theholder. Again, the holder 120 includes the handle 122, hub 124, andtemplate 126. The template 126 may be fixed in a perpendicularorientation with respect to the handle 122, or may be capable ofpivoting as described above. The attachment sutures 128 desirably extendradially inward around a guide 132 having a slot 134. A cutting blade136 arranged to translate within the hub 124 lines with each slot 136.At the desired time, the cutting blades 136 simultaneously translatedownward through the slots 134 to sever the attachment sutures 128.Although the mechanism for actuating the cutting blade 136 is not shown,it may comprise a simple pushrod extending through the handle thatsimultaneously displaces the three blades 36. Alternatively, a pull wiremay be used.

FIG. 12 is a perspective view of the distal end of a further exemplaryannuloplasty ring holder 140 showing a mechanism for remotely detachingthe annuloplasty ring AR from the holder. Again the holder 140 includesthe handle 142, hub 144, and template 146. The template 146 may be fixedin a perpendicular orientation with respect to the handle 142, or may becapable of pivoting as described above. As in the embodiment of FIG. 10,each of the attachment sutures 148 passes over a template guide 152. Apull wire 154 for each of the loops of the attachment sutures 148extends outward from the hub 144. FIG. 12A is a close-up of thedetaching operation of the pull wires 154. Namely, the pull wire 154 isarranged to apply concentrated stress to each of the attachment sutures148 and sever it at the template guide 152. The mechanism for actuatingthe pull wires 154 is not shown, although a reel/knob taking up theproximal ends of each of the pull wires 154 and actuated throughmechanical advantage is a likely configuration.

To improve visualization, it is desirable to add illumination byembedding a light source on the distal end of the holders describedherein. To energize the light source, a battery or other power sourcemay be incorporated into the handle. FIG. 13 is a side view of oneilluminated annuloplasty ring holder 160. The holder 160 includes theproximal handle 162 and distal template 164. A light source 166, such asan LED, forms the terminal end of a malleable wire 168 and projectstoward the template 164. The malleable wire 168 may be closely heldagainst the bendable handle 162 so that the light source 166 alwayspoints toward the template 164.

In addition, it may also be desirable to add optics so as to visualizethe inside of the heart from the proximal end of the handle. FIG. 14 isa side view of an annuloplasty ring holder 170 having both a source ofillumination and means for visualization. The holder 170 includes aproximal handle 172 and distal template 174. A light source 176 on theend of the malleable wire 178 may be energized using a battery withinthe handle 172. In addition, an optic lens 180 arranged adjacent thelight source 176 connects through an optic fiber 182 to a proximalviewer 184. The viewer 184 includes an ocular device that permits theuser to easily and rapidly see the area around the annuloplasty ringtemplate 174 during an implant operation.

FIGS. 15A and 15B illustrate an alternative active annuloplasty ringholder 200. The holder 200 comprises an elongated handle 202 and anannuloplasty ring template 204 pivotally attached to a distal endthereof. The template 204 defines a peripheral edge 206 sized to receivean annuloplasty ring 208. As will be explained in detail below, aplurality of sutures attach the annuloplasty ring 208 to the template204.

FIG. 15B shows that the elongated handle 202 comprises three primarysections: a proximal section 210, a middle section 212, and a distalsection 214. The proximal section 210 consists of a hollow housing,typically molded plastic, which is larger in diameter than the other twosections and has an ergonomic shape to facilitate grasping by thesurgeon. The middle section 212 is an elongated hollow tube throughwhich control elements extend, as will be described below. The distalsection 214 is also formed by a hollow housing that terminates in abifurcated yoke 216. Like the embodiments described above, the overalllength of the holder 200 is between 200-250 mm, and preferably about 230mm. The middle section 212 has a length of between 80-120 mm, andpreferably about 100 mm, and may be malleable as described above, but ispreferably relatively rigid to enable functioning of pull/push rodspassing therethrough. The materials used in the handle sections, as wellas the other elements of the holder 200, may be any suitablebiocompatible plastic or metal.

FIG. 16A is a close-up of a pivot actuator 220 and locking mechanism 222on the proximal section 210 of the handle 202, while FIG. 16B shows aportion of the proximal section housing removed to illustrate certaininternal components. The pivot actuator 220 translates linearly alongthe handle 202 to pivot the distal annuloplasty ring template 204. Anexemplary pivoting mechanism will be described with respect to FIG. 17,although those skilled in the art will understand with reference toother embodiments described herein that there are other ways to pivotthe template 204.

The locking mechanism 222 permits the user to fix the position of thepivot actuator 220, therefore fixing the angle of the template 204 withrespect to the longitudinal axis of the handle 202. The handle 202defines a recess 224 and a slot 225 within which the pivot actuator 220translates. In the illustrated embodiment, the actuator 220 and recess224 are substantially lenticular. A plurality of ratchet teeth 226extend inward on both sides of the slot 225 and engage mating pawl orteeth (not shown) on the underside of the actuator 220. A small lockingbutton 228 projecting upward from the top surface of the actuator 220enables selective retraction of the mating pawl. Although the details ofthe locking button 228 are not shown, an exemplary embodiment includes alever or cam that retracts the mating pawl(s) when the locking button isdepressed, and a spring element that biases the locking button upward soas to automatically lock the position of the actuator 220. The user candepress the locking button 228 in order to slide the actuator 220. Asmall tube 229 fixed with respect to the actuator 220 receives andanchors to a push/pull rod 230 that is part of a pivoting mechanism 232described below. Although a linear actuator 220 is shown, otheractuators like rotating knobs or hinged triggers may be utilized, andthe particular motion of the actuator may be modified.

FIG. 17 illustrates the distal segment of the ring holder 200 of FIG.15A with a portion of the handle 202 removed to illustrate the internaltemplate pivoting mechanism 232. At its proximal end, the pivotingmechanism 232 includes the push/pull rod 230 that translates linearlywithin the lumen of the handle 202. Although not shown, the push/pullrod 230 firmly attaches to and translates with the pivot actuator 220.Push/pull rod 230 travels through a linear bearing 234 within the handle202 for support. A hinge 236 connects the push/pull rod 230 to a linkarm 238. The distal end of the link arm 238 is hingedly connected to aneccentric projection 240 of a pivot member 242, also seen in FIG. 19A.The pivot member 242, in turn, mounts for rotation within the yoke 216at the distal end of the handle 202. Specifically, the pivot member 242includes a pair of opposed pivot pins 244 that are received within apair of through holes in each arm of the yoke 216. Linear translation ofthe push/pull rod 230 displaces the link arm 238 which, through itshinged connection to the eccentric projection 240, rotates the pivotmember 242 about the common axis of the pivot pins 244.

FIGS. 18A-18E show a number of positions in which an annuloplasty ringtemplate 204 may be pivoted by operation of the pivoting mechanism 232.In an equilibrium position in FIG. 18C, the template 204 is orientedperpendicular to the axis of the handle 202. In the illustratedembodiment, the template 204 has a planar configuration but templatesthat are non-planar may also be utilized. For instance, rings andcorresponding templates that have three dimensions with one or more bowsout of a reference plane are becoming more prevalent, and may be mountedon the active holder disclosed herein.

In any event, the active holder 200 desirably permits pivoting rotationof the template 204 within a range of up to about 180°. FIG. 18A showsthe template 204 pivoted counterclockwise an angle θ₁ of nearly −90°from the horizontal, FIG. 18B shows an angle θ₂ of about −45°, FIG. 18Dshows a clockwise rotation to an angle θ₃ of about 45°, and FIG. 18Eshows a farther clockwise rotation to an angle θ₄ of nearly 90°. Each ofthese orientations may be useful during delivery of annuloplasty ring.Furthermore, rotating the template 204 reduces the horizontal dimensionof the active holder 200 and permits the insertion through relativelysmaller spaces than would be the case without rotation.

The active holder 200 further includes a mechanism for remotelydetaching the annuloplasty ring 208 from the template 204. In aconventional system, the annuloplasty ring attaches to the template viaa plurality of sutures which are tied to the template and cross over oneor more cutting guides. The surgeon severs the sutures at the cuttingguides to release the annuloplasty ring, which requires scalpel accessto the template at the site of implantation. The holder disclosed hereinprovides a remote detaching mechanism that desirably can be operatedfrom the proximal end of the handle 202.

FIGS. 19A-19D illustrate the annuloplasty ring template 204 and elementsof a mechanism for securing and easily detaching an annuloplasty ringaround the template. As mentioned above, the template 204 generallydefines a planar body 252 and has a peripheral edge 206 sized to receivean annuloplasty ring 208 (see FIG. 15A). The illustrated template 204 issized and shaped to receive a mitral annuloplasty ring, and as such hasa generally oval- or D-shaped periphery.

Various exemplary annuloplasty rings may be utilized in conjunction withthe holders disclosed herein, and preferably comprise a flexible, stiff,or deformable support ring covered by a fabric or mesh suitable forsuturing the annuloplasty ring to heart tissue. The support ring may bea biocompatible metal such as stainless steel or titanium or a flexiblematerial such as silicone rubber or Dacron cordage, depending upon thestructural and performance characteristics desired in the ring. Theoverlying fabric or mesh may be a polyester knit fabric, polyestervelour cloth, expanded polytetrafluoroethylene, or other biocompatibleporous material with sufficient structural integrity to resist tearingwhen a suture is passed through it and secured to the heart. The holdersdisclosed herein may be adapted for use with any of the variouscommercially available annuloplasty rings, including the rigidCarpentier-Edwards Classic® ring, the semi-flexible Carpentier-EdwardsPhysio®, or the flexible ring Cosgrove-Edwards® annuloplasty ring, allavailable from Edwards Lifesciences, Irvine, Calif. Other rings includethe SCULPTOR or DURAN rings available from Medtronic, Inc. ofMinneapolis, Minn., the PUIG MASSANA ring available from Sorin Biomedicaof Salaggia, Italy, or the BIFLEX Ring available from St. Jude Medical,Inc. of St. Paul, Minn.

The holders disclosed herein are configured to hold annuloplasty ringsof various shapes and sizes. Specifically, the present holders may beadapted for holding D-shaped split annuloplasty rings, D-shapedcontinuous annuloplasty rings, or C-shaped split or open annuloplastyrings. The embodiment of the template 204 illustrated in FIG. 19A has aC- shaped configuration with the peripheral edge 206 extendingapproximately two thirds of the way around the template body 252. Otherannuloplasty ring shapes may also be used with the holder, includingkidney-shaped, saddle-shaped racetrack-shaped, semicircular, circular,and others. Mitral rings and corresponding holders typically haveorifice sizes that range in even millimeter increments from 24 mm to 40mm, as measured across the major axis. In some cases, the annuloplastyring may be flexible and may have a shape in a natural, unstressedcondition which is different than the shape of holder. For example, acircular ring could be held by a D-shaped holder. In this way, the ringconforms to the shape of holder and is held in the shape it will be inwhen secured within the heart. The ring may also be malleable so that itmay be bent into the shape of the holder and/or reshaped by the surgeonat the time of implantation within the heart.

The peripheral edge 206 of the exemplary template 204, as seen in FIGS.19A and 19B, comprises a proximal lip 254, a distal rail 256, and anoutwardly directed channel depression 258 therebetween. As seen in FIG.15A, the proximal lip 254 forms a radially outward extension of the flatproximal side of the template body 252. The distal rail 256 projectsdistally from the underside of the template body 252 and is radiallyinset from the outer edge of the proximal lip 254. The channel 258 istherefore defined between the substantially perpendicular lip 254 andrail 256, although all of the respective surfaces are smoothly curvedsuch that the channel substantially mirrors the tubular outer peripheryof typical annuloplasty rings.

The template 204 features a number of holes and depressions forthreading and guiding sutures therethrough. Some of the sutures are usedto secure an annuloplasty ring within the channel 258 on the peripheraledge 206, while some of the sutures are used to secure the handle 202,and more specifically the pivot member 242, to the template 204. FIG.19A shows the under- or distal side of the template 204 while FIG. 19Bshows the top or proximal side. To better illustrate the sutureholes/grooves, an annuloplasty ring 208 and connecting sutures are onlyshown in FIG. 19B.

A series of outer holes 270 extend through from the channel 258 to theradially inner side of the rail 256. The annuloplasty ring 208 residesin the channel 258 when connected, and as will be seen, a plurality ofsutures pass outward through the rail 256, through the suture-permeablering, and back inward through the rail. Just inward from three of theouter holes 270 are located pairs of template body holes 272. The holes272 extend all the way through the template body 252, and can be seen onthe proximal side in FIG. 19B. Four rectangularly spaced handle holes274 also pass completely through the template body 252. Two lineargrooves 276 in the distal face of the template body 252 connect twopairs of the four handle holes 274.

Still with reference to FIG. 19A, a ring release pin 280 in an extendedposition projects distally through a bore (not numbered) in the templatebody 252, located generally centrally and between the linear grooves276. As will be seen, the release pin 280 is movable in the bore betweenthe extended position in FIG. 19A and a retracted position shown in FIG.19D. Also seen in FIG. 19A is the bottom end of a handle release pin282, which will be described below.

Now with reference to FIGS. 19B and 19C, an exemplary arrangement ofsutures for mounting the annuloplasty ring 208 to the template is shown.Three double ring attachment sutures 284 a, 284 b, 284 c thread downwardfrom the proximal side of the template 204, outward through the ring208, and inward to loop around the ring release pin 280, as seen in FIG.19C. Each double suture 284 a, 284 b, 284 c passes through the template204 and ring 208 as two parallel threads with free ends that diverge topass through different template body holes 272 and knot together on theproximal side of the template body 252, as seen in FIG. 19B. Morespecifically, the sutures 284 a, 284 b, 284 c are routed outward fromthe template body holes 272 across the distal face of the template body252 and pass outward through the outer holes 270 in the distal rail 256(see FIG. 19A). The sutures 284 a, 284 b, 284 c are threaded through oralong portions of the ring 208, as seen in dashed line in FIG. 19C, andthen pass inward through outer holes 270 in the distal rail 256 and looparound the ring release pin 280. The closed end of each suture 284 a,284 b, 284 c therefore loops around the release pin 280 in its extendedposition, as seen in FIG. 19C to attach the annuloplasty ring to thetemplate.

FIG. 19D shows the template 204 being pulled free of the annuloplastyring 208. This step occurs after the ring 208 has been anchored to theannulus under repair. That is, the surgeon uses the handle 200 toadvance the ring 208 into position along a plurality of pre-attachedsuture loops around the annulus. Each of the anchoring sutures are thentied off on the proximal side of the ring 208. The template 204maintains the ring 208 in a desired shape during the anchoringprocedure. Once the ring is secured to the annulus, the surgeon remotelyactuates the ring release pin 280 to displace it to its retractedposition seen in FIG. 19D, with its distal end flush with or above thedistal face of the template body 252. Movement of the pin 280 to theretracted position frees the suture loops 284 a, 284 b, 284 c to detachthe annuloplasty ring 208 from the template 204. That is, once the loopsare free, the template 204 may be displaced proximally, and the freeends of each suture 284 a, 284 b, 284 c that are tied to the templatepull the closed loops from within their paths in the ring 208. Thisdetachment step is seen occurring in FIG. 19D.

It should be noted that although the traditional parachute array ofpre-attached anchoring sutures is desirably used to secure theannuloplasty ring 208 to the annulus, other anchoring means are possiblewithout affecting the use of the exemplary active holder 200. Forinstance, the process may be expedited with the use of staples, orremote suturing methods. Any of the foregoing or other implantationmethods may also be used.

The handle 202 is also detachably connected to the template 204, and maybe remotely disconnected. With reference again to FIGS. 19A and 19B, twodouble threads 290 a, 290 b include free ends that are tied throughholes 292 to one side flange 294 of the pivot member 242 of the handle202 (shown removed in FIG. 19B for clarity). The double threads 290 a,290 b pass downward through the two holes 292 in the flange 294 thatalign with two of the handle holes 274 in the template body 252. Thedouble threads 290 a, 290 b then extend along the grooves 276 as seen inFIG. 19A and pass upward through the other pair of handle holes 274 andtwo aligned holes 296 in another flange 298 on the pivot member 242, asseen in FIG. 19B. The double threads 290 a, 290 b then loop around aprojecting portion of the handle release pin 282.

FIGS. 20A and 20B illustrate the distal end of the holder 200 and showthe connection of two pull wires 300, 302 for, respectively, releasingthe annuloplasty ring 208 and handle 202 from the template 204. A ringrelease pull wire 300 extends distally through the handle 202 and firmlyconnects to the ring release pin 280. The ring release pin 280 desirablyincludes cantilevered features (not numbered) on its exterior to engagemating features in the corresponding template bore and preventinadvertent movement. Tension applied to the pull wire 300 will displacethe release pin 280 from its extended position to its retractedposition, and release the ring 208 from the template 204. It should beunderstood that the term “pull wire” refers to any biocompatibleflexible filament that has sufficient strength to transmit the tensionrequired to move the release pin 280.

The handle release pull wire 302 extends distally through the handle 202and firmly connects to the handle release pin 282. The handle releasepin 282 also desirably includes cantilevered features on its exterior toengage mating features in the corresponding template bore and preventinadvertent movement. Tension applied to the pull wire 302 will displacethe release pin 282 from its extended position to its retractedposition, and release the handle 202 from the template 204.

FIGS. 21A and 21B show the proximal end of the handle 202 and operationof both ring and handle release actuators therein. A pulley mechanism310 ensures that while the handle 202 is withdrawn from the template204, the ring release pin 280 will not also be drawn back. Specifically,the ring release pull wire 300 travels through the handle and anchors tothe shaft 312 of the pulley mechanism 310. The shaft 312 carries on oneor both ends a triangular stop member 314. The pulley mechanism 310mounts in the bore of a tubular sleeve 316 arranged to slide linearlywithin the housing of the handle distal section 214. A ring releasebutton 318 caps the proximal end of the tubular sleeve 316. Between thepulley mechanism 310 and the ring release button 318, the housing 214defines a larger bore in which is positioned a spring 320 in contactwith a collar 322 having a triangular notch 324. The triangular notch324 is shaped, sized, and aligned to mate with the triangular stopmember 314 if the ring release button 318 and tubular sleeve 316 aredisplaced in a proximal direction. In the configuration of FIG. 21A theshaft 312 is free to rotate.

FIG. 21A also illustrates the handle release pull wire 302 as it travelsthrough the handle 202 and anchors to the distal end of a handle releaseshaft 330 and button 332. Detachment of the handle 202 from the template204 occurs by pulling the handle release button 332 as indicated byarrow 336, which applies tension to the handle release pull wire 302 anddisplaces the release pin 282 from its extended position to itsretracted position, as seen in FIG. 20B.

Detachment of the ring 208 from the template 204 occurs by pulling thering release button 318 as indicated by arrow 338 in FIG. 21B, whichapplies tension to the ring release pull wire 300 and displaces therelease pin 280 from its extended position to its retracted position, asalso seen in FIG. 20B. Pulling the ring release button 318 pulls thetriangular stop member 314 into the triangular notch 324 of the collar322, which prevents rotation of the shaft 312 and uncoiling of the pullwire 300 from the pulley mechanism 310.

If the surgeon wishes to just detach the handle 202 from the template204, he or she can pull the handle release button 332 and then theentire handle 202, as indicated by arrow 340 in FIG. 21A. Because thetriangular stop member 314 remains spaced from the triangular notch 324the shaft 312 is permitted to uncoil from the pulley mechanism 310,which prevents undue tension being placed on the ring release pull wire300.

FIG. 22 is a distal perspective view of the annuloplasty ring template204 assembled with a release pin cover 250 thereon. The cover 250prevents inadvertent deployment of the ring release pin 280 from itsextended position to its retracted position, thereby protecting theassembly from accidental ring detachment. The cover 250 can be removedjust before implantation of the ring 308.

FIG. 23 is a distal perspective view of an alternative annuloplasty ringtemplate 260 similar to that of FIG. 15A but with spokes 262 and windows264 for greater visibility. The windows 264 permit the surgeon to viewthe distal side of the assembly during the process of advancing the ringinto implant position, and while the ring is anchored to the annulus.Preferably there are four spokes 262 and three windows 264, though otherconfigurations are possible.

While the invention has been described in its preferred embodiments, itis to be understood that the words which have been used are words ofdescription and not of limitation. Therefore, changes may be made withinthe appended claims without departing from the true scope of theinvention.

What is claimed is:
 1. A combination holder and annuloplasty ring,comprising: a template having a peripheral edge sized to receive anannuloplasty ring; an annuloplasty ring attached around the peripheraledge of the template with a plurality of sutures; a handle, wherein thetemplate mounts at a distal end of the handle; a ring detachmentmechanism for detaching the sutures attaching the annuloplasty ring tothe template, the ring detachment mechanism being remotely actuated froma proximal end of the handle and including an element on the templatemovable between a first position that maintains the plurality of suturesin positions attaching the annuloplasty ring to the template and asecond position that frees the plurality of sutures to move and enabledetachment of the template from the annuloplasty ring.
 2. Thecombination of claim 1, wherein the handle has a pivot on which thetemplate pivots to a variety of angles with respect to the handle, andfurther including a pivoting mechanism in the handle for pivoting thetemplate.
 3. The combination of claim 2, wherein the pivoting mechanismincludes a push/pull rod linearly movable within the handle andconnected to an eccentric projection of a pivot member on which thetemplate mounts.
 4. The combination of claim 2, further including alocking mechanism in the handle that permits a user to fix the angle ofthe template with respect to the handle.
 5. The combination of claim 4,wherein the pivoting mechanism enables approximately 180° of rotation ofthe template.
 6. The combination of claim 1, wherein the element is aring release pin movable in a bore in the template, and the ringdetachment mechanism includes a pull wire extending distally from thehandle that connects to and retracts the ring release pin to detach theannuloplasty ring from the template, wherein each of the plurality ofsutures is tied to the template and passes through the annuloplasty ringand has a loop held around the ring release pin projecting from a distalface of the template, wherein retraction pulls the ring release pinproximally into the bore in the template to free the loops of theplurality of sutures so that they can be pulled free of the annuloplastyring.
 7. The combination of claim 6, wherein the template has an outergroove at the peripheral edge in which the annuloplasty ring isreceived, and each of the plurality of sutures passes outward through ahole in the template opening to the groove, into and along a portion ofthe annuloplasty ring, out of the annuloplasty ring and back inwardthrough a second hole in the template opening to the groove and thenforms the loop that is held around the ring release pin.
 8. Thecombination of claim 1, further including a handle release pull wireconnected between the handle and a handle release pin positioned in abore in the template that secures the template to the distal end of thehandle, wherein retraction of the handle release pull wire pulls thehandle release pin from the bore in the template and detaches the handlefrom the template.
 9. The combination of claim 1, further including: asource of illumination mounted on the handle and directed toward thetemplate; and an optic lens mounted on the handle and directed towardthe template, and a viewer mounted at a proximal end of the handlepermits a user to visualize the template through the lens.
 10. Thecombination of claim 9, wherein the source of illumination is mounted atthe end of a malleable wire extending along the handle, and wherein aportion of the handle is malleable.
 11. A combination holder andannuloplasty ring, comprising: a template having a peripheral edge sizedto receive an annuloplasty ring; an annuloplasty ring attached aroundthe peripheral edge of the template with a plurality of sutures each ofwhich is tied to the template and passes through the annuloplasty ringand has a loop held around a ring release pin in the template; a handle,wherein the template mounts at a distal end of the handle; a ringdetachment mechanism for detaching the sutures attaching theannuloplasty ring to the template, the ring detachment mechanismincluding a ring release pull wire actuated from a proximal end of thehandle to displace the ring release pin and free the loops of theplurality of sutures so that they can be pulled free of the annuloplastyring and detach the template from the annuloplasty ring.
 12. Thecombination of claim 11, further including a handle release pull wireconnected between the handle and a handle release pin positioned in abore in the template that secures the template to the distal end of thehandle, wherein retraction of the handle release pull wire pulls thehandle release pin from the bore in the template and detaches the handlefrom the template.
 13. The combination of claim 12, further including aring release button in the handle connected to the pull wire, such thata user may displace the ring release pin by pulling the ring releasebutton, wherein the ring release pull wire connects on its proximal endto a pulley mounted to translate with the ring release button, whereinthe pulley is free to rotate unless the user pulls the ring releasebutton so that the handle may be detached from the template withoutapplying tension to the ring release pull wire and detaching thetemplate from the annuloplasty ring.
 14. The combination of claim 11,wherein the handle has a pivot on which the template pivots to a varietyof angles with respect to the handle, and further including a pivotingmechanism in the handle for pivoting the template.
 15. The combinationof claim 14, wherein the pivoting mechanism includes a push/pull rodlinearly movable within the handle and connected to an eccentricprojection of a pivot member on which the template mounts.
 16. Thecombination of claim 14, further including a locking mechanism in thehandle that permits a user to fix the angle of the template with respectto the handle.
 17. The combination of claim 16, wherein the pivotingmechanism enables approximately 180° of rotation of the template. 18.The combination of claim 11, wherein the ring release pin projects froma distal face of the template is movable into a bore in the templateand, and wherein retraction pulls the ring release pin proximally intothe bore to free the loops of the plurality of sutures held around thering release pin so that they can be pulled free of the annuloplastyring.
 19. The combination of claim 18, wherein the template has an outergroove at the peripheral edge in which the annuloplasty ring isreceived, and each of the plurality of sutures passes outward through ahole in the template opening to the groove, into and along a portion ofthe annuloplasty ring, out of the annuloplasty ring and back inwardthrough a second hole in the template opening to the groove and thenforms the loop that is held around the ring release pin.
 20. Thecombination of claim 11, further including: a source of illuminationmounted on the handle and directed toward the template; and an opticlens mounted on the handle and directed toward the template, and aviewer mounted at a proximal end of the handle permits a user tovisualize the template through the lens.
 21. The combination of claim20, wherein the source of illumination is mounted at the end of amalleable wire extending along the handle, and wherein a portion of thehandle is malleable.